CompletedPhase 2

Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients

United States175 participantsStarted 2004-03

Plain-language summary

Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients included in this study will be those admitted to the trauma intensive care unit (TICU) of Erie County Medical Center (ECMC) hospital. All patients admitted to the TICU who are intubated and mechanically ventilated within 24-48 hours of admission will be eligible for study admission, with the exception of those demonstrating the following exclusion criteria: a) a witnessed aspiration (to eliminate patients with chemical pneumonitis); b) a confirmed diagnosis of post-obstructive pneumonia (e.g. advanced lung cancer); c) a known hypersensitivity to CHX; d) patients for whom consent can not be obtained; e) a diagnosed thrombocytopenia (platelet count less than 40 and/or a INR above 2) or other coagulopathy; f) a do not intubate order; g) children under the age of 18 years; h) Pregnant women; i) Legal incarceration; j) If transferred from another ICU; k) Those with oral mucositis; l) Those with immunosuppression (either-HIV or drug induced \[e.g. organ transplant patients or those on long term steroid therapy\]); m) Patients re-admitted to the TICU * Comatose and intubated patients will be included since they represent patients at greatest risk for respiratory infection. Exclusion Criteria: * Patients for whom consent can not be obtained.

What they're measuring

Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours

Timeframe: Every 48 hours until discharge

Trial details

NCT IDNCT00123123

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-11

Results submitted2010-08-12